Label: LEG CRAMPS AND SPASMS- calcarea carbonica, cuprum metallicum, gnaphalium polycephalum, hyoscyamus niger, ignatia amara, magnesia phosphorica, nux vomica, passiflora incarnata, platinum metallicum, plumbum metallicum, secale cornutum, strychninum, liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0435-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 8, 2015
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Calcarea carbonica, Cuprum metallicum, Gnaphalium polycephalum, Hyoscyamus niger, Ignatia amara, Magnesia phosphorica, Nux vomica, Passiflora incarnata, Platinum metallicum, Plumbum metallicum, Secale cornutum, Strychninum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
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- DOSAGE & ADMINISTRATION
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEG CRAMPS AND SPASMS
calcarea carbonica, cuprum metallicum, gnaphalium polycephalum, hyoscyamus niger, ignatia amara, magnesia phosphorica, nux vomica, passiflora incarnata, platinum metallicum, plumbum metallicum, secale cornutum, strychninum, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0435 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 59 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X] in 59 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 10 [hp_X] in 59 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 10 [hp_X] in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 10 [hp_X] in 59 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 59 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 59 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 59 mL PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM 10 [hp_X] in 59 mL LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD 10 [hp_X] in 59 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_X] in 59 mL STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0435-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/06/2012 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0435)
